Interwoven Nitinol Stents versus Drug Eluting Stents in the Femoro-Popliteal Segment: A Propensity Matched Analysis

Abstract

WHAT THIS PAPER ADDS Percutaneous transluminal angioplasty (PTA) is a common treatment for femoro-popliteal segment (F-P) atherosclerotic disease. The use of biomimetic nitinol stents (Supera peripheral stent, SPS) or drug eluting stents (DES) may improve F-P PTA patency. These devices, however, have not been compared in a pragmatic setting taking plaque characteristics into account. This case matched analysis shows that SPS and DES have comparable results in F-P PTA. Using a DES did not confer a measurable benefit in terms of patency or clinical results at two years. At the same time, the SPS also did not confer a benefit in the heavily calcified plaques. Background: Percutaneous transluminal angioplasty (PTA) is a common procedure in patients with peripheral arterial disease (PAD) affecting the femoropopliteal segment (F-P). Biomimetic nitinol stents (Supera peripheral stent, SPS) and drug eluting stents (DES) were designed to improve the longevity of F-P PTA; however, their performance has not been compared in a pragmatic setting, taking atherosclerotic plaque characteristics into account. Methods: Overall, 296 consecutive patients (mean age: 73 y, SD: 11 y, 65% male, 68% with chronic limb threatening ischaemia) who underwent F-P PTA using SPS or DES between 2013 and 2018 were identified from a prospectively maintained institutional database. Patient and plaque characteristics, including F-P plaque characterisation based on computed tomography, were collected; 121 case matched pairs were created using a propensity score based on patient and plaque data. Results: During the median two year follow up, 28% of the cohort (32% SPS vs. 24% DES, p ¼ .07) developed target lesion restenosis (TLR) > 50%. Among the 121 case matched pairs of patients, those with SPS vs. DES were not significantly more likely to develop TLR >50% (31% vs. 27%, p ¼ .34), or stent occlusion (13% vs. 12%, p ¼ .85 e secondary patency rate 87% vs. 88%), have a major amputation (10% vs. 6%, p ¼ .16), require re-intervention (14% vs. 9%, p ¼ .12), or die (7% vs.4%, p ¼ .31). Plaque calcification did not predict restenosis or occlusion in either stent group, both in the matched and non matched populations. Multivariable analysis adjusted for patient and plaque characteristics revealed that the main predictors of restenosis >50% at two years were female sex [odds ratio (OR): 2.05, p ¼ .01], hypertension (OR: 2.10, p ¼ .04) and previous F-P occlusion (OR: 1.35, p ¼ .04). Conclusion: Medium term results following F-P PTA with either SPS or DES are comparable, regardless of plaque calcification and patient characteristics.

A Paclitaxel Free Alternative in the War Against Drugs?

“…In the current issue of the European Journal of Vascular and Endovascular Surgery, Saratzis et al report the results of the direct comparison between interwoven nitinol stents (i.e., Supera) and drug eluting stents (DES) in the femoropopliteal segment using propensity matched analysis. 1 They report that in a heterogeneous single centre population target lesion restenosis, target lesion revascularisation, major amputation, and mortality are similar for the Supera and DES group at a median follow up of two years.…”

“…3e6 Saratzis et al confirm these observations in a direct comparison, and also that at a median of two years follow up no significant differences between the Supera and DES group were observed. 1 However, are we now convinced that Supera stents can replace DES in the treatment of femoropopliteal lesions? Target lesion restenosis rates were 32% and 24% for the Supera and DES groups, respectively (p ¼ .07) and the need for reintervention rates were 14% and 9%, respectively (p ¼ .12).…”

“…7 Another issue in considering the results of Supera stents is the influence of packing on treatment results. 8 The best results are obtained with stent compression, but no data on stent compression are available in the study of Saratzis et al, 1 and therefore its effect cannot be assessed. However, everybody who has ever used a Supera stent knows that its deployment is somewhat more complex than that of most of the other self expandable stents, which could result in more heterogeneous results or at least requires a learning curve.…”

“…Potential alternatives in no-stent areas might be mechanical or laser atherectomy devices. And based on the data of Saratzis et al, 1 interwoven nitinol stents could fill the (temporary) gap left behind by the paclitaxel eluting devices until further data become available.…”

One Year on: Test Your Knowledge From November 2019

“…D. There is a lack of published evidence-based quality indicators concerning endovascular treatment for PAOD E. None of the above 13. The use of an interwoven nitinol stent as part of superficial femoral artery angioplasty is associated with: 13 A. Higher need for re-intervention over one year compared to using drug eluting stents B.…”